Foster and Thrive Daytime Cold and Flu Relief

Description

Foster & Thrive™ DAYTIME Cold & Flu Relief is a multi-symptom relief formulation designed to alleviate symptoms associated with cold and flu. The active ingredients include acetaminophen, which serves as a pain reliever and fever reducer; phenylephrine HCl, a nasal decongestant; and dextromethorphan HBr, a cough suppressant. This product is non-drowsy, gluten-free, and alcohol-free, providing effective relief without sedation. The dosage form is a liquid, available in an 8 FL OZ (237 mL) container.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, cough due to minor throat and bronchial irritation, sore throat, headache, minor aches and pains, and fever.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe allergic responses.

Additionally, do not exceed the recommended dosage.

Warnings and Precautions

Severe liver damage may occur with the use of this product containing acetaminophen under certain conditions. Adults should not exceed 4,000 mg of acetaminophen within a 24-hour period. For children, the maximum is 5 doses in the same timeframe. Caution is advised when this product is taken in conjunction with other medications containing acetaminophen. Additionally, adults consuming three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should be vigilant regarding sore throat symptoms. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is recommended.

General precautions should be taken before using this product. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, individuals with a persistent or chronic cough, such as those with smoking-related conditions, asthma, or emphysema, should seek medical advice prior to use. It is also advisable to consult a doctor or pharmacist if the patient is currently taking the anticoagulant warfarin.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent.

Patients should discontinue use and contact their healthcare provider if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness. Furthermore, if pain, nasal congestion, or cough worsens or persists beyond five days in children or seven days in adults, or if fever worsens or lasts more than three days, medical advice should be sought. Redness or swelling, as well as a cough that recurs or is accompanied by a rash or headache lasting longer than expected, may indicate a serious condition requiring further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of acetaminophen, specifically if an adult takes more than 4,000 mg within a 24-hour period, or if a child takes more than 5 doses in the same timeframe. The risk of liver damage is further increased when acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than two days or is accompanied by symptoms such as fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

Patients should discontinue use and consult a doctor if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts beyond 5 days in children or 7 days in adults, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, as well as a cough that recurs or occurs with a rash or headache lasting for an extended period, may indicate a serious condition requiring medical evaluation.

Before using this product, patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland should consult a healthcare provider. Those experiencing a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using acetaminophen.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this product if they are concurrently taking warfarin, a blood-thinning medication, due to the potential for increased bleeding risk.

Co-administration with any other product containing acetaminophen, whether prescription or over-the-counter, is contraindicated. Patients are advised to verify the presence of acetaminophen in any other medications they may be taking by consulting a healthcare professional.

This product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it is important to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Patients uncertain about the presence of an MAOI in their current medications should seek guidance from a healthcare professional before use.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive Daytime Cold and Flu Relief (acetaminophen, dextromethorphan hbr, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may receive a dosage of 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a healthcare professional before administration. The use of this medication is not recommended for children under 4 years of age.

In the event of an overdose, it is crucial to seek immediate medical attention for pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and clearance. Monitoring of liver function may be necessary to ensure safety and efficacy in this patient population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary depending on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. They should also be instructed to discontinue use and consult a doctor if they experience new symptoms, or if they feel nervous, dizzy, or have trouble sleeping.

Healthcare providers should inform patients to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists beyond 5 days for children or 7 days for adults. Additionally, patients should be advised to consult a doctor if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. They should also be instructed to seek medical attention if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients should be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, or emphysema.

Finally, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures or humidity.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the medication out of reach of children to ensure safety. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Foster and Thrive Daytime Cold and Flu Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)